APPLICATION
ANDA062432
TYPE
ANDA
ORIGINAL APPROVAL
1983-02-15
LATEST ACTION
2026-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DOXYCYCLINE HYCLATEDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE · TABLET · ORAL
Approval history
2026-01-18Labeling · Supplement 45 · standardAP
2025-03-31Labeling · Supplement 44 · standardAP
2023-09-05Labeling · Supplement 35 · standardAP
2023-09-05Labeling · Supplement 33 · standardAP
2023-09-05Labeling · Supplement 31 · standardAP
2023-09-05Labeling · Supplement 38 · standardAP
2023-09-05Labeling · Supplement 28 · standardAP
2023-09-05Labeling · Supplement 30 · standardAP
2017-07-28Manufacturing (CMC) · Supplement 32 · unknownAP
2015-06-30Labeling · Supplement 26 · standardAP
2014-09-02Labeling · Supplement 24 · standardAP
2002-12-23Labeling · Supplement 23AP
1996-03-14Labeling · Supplement 20AP
1993-06-01Labeling · Supplement 15AP
1992-12-16Labeling · Supplement 14AP
1991-09-24Labeling · Supplement 13AP
1991-07-16Labeling · Supplement 12AP
1983-02-15OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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